A Single Arm Pilot Study to Refine a Novel Approach to Exercise Promotion Based on Affect-regulation

Not Applicable

Completed

Conditions: Breast Cancer

Interventions: Behavioral: Core Exercise Promotion Intervention

Registration Number: NCT04903249

Lead Sponsor: Dartmouth-Hitchcock Medical Center

Brief Summary: The purpose of this study is to refine the use of an affect-regulated exercise prescription for use with survivors of breast cancer.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 37

Inclusion Criteria

Within 5 years of completing curative treatment (surgery, chemotherapy, and radiation) for stage 0-III breast cancer
<60 mins/week moderate-vigorous physical activity with no major changes for the past 6-months
Own an Android or iPhone smartphone and willing to use the smartphone to complete app-based surveys during assessment periods
Willing to wear the ActiGraph monitor during assessment periods
Access to internet to complete REDCap survey assessments

Exclusion Criteria

Non-English speaking/not able to read English
Evidence of major contraindications for exercise (informed by the 2020 Physical Activity Readiness-Questionnaire (PAR-Q)+)
Currently pregnant
History of severe mental illness or currently taking mood stabilizing medications (antipsychotics, anticonvulsants, or lithium)
Evidence of moderate-severe depressive symptoms (indicated by a score ≥10 on Patient Health Questionnaire-8)
Evidence of moderate-severe cognitive impairment (indicated by a score < 3 on a 6-item cognitive screener)
Evidence of clinically significant substance use as indicated by a score of ≥2 on the CAGE-AID screener

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Affect-regulated exercise prescription	Core Exercise Promotion Intervention	Participants receive instructions to adjust their pace of exercise so that they feel "fairly good" or better (i.e., a rating of +1 or higher on the Feeling Scale) while exercising and to avoid any increases in intensity that promote feeling "fairly bad" or worse. If no intensity of exercise feels at least "fairly good" participants will be told to exercise at an intensity that feels "as positive as possible."

Primary Outcome Measures

Name	Time	Method
Acceptability of the Affect-regulated Exercise Prescription Measured Using the Treatment Acceptability and Preferences (TAP) Measure	12-weeks follow-up assessment	A 4-item self-report questionnaire used to measure acceptability of the affect-regulated exercise prescription using a Likert scale ranging from 0 (not at all) to 4 (very much). Total scores range from 0 - 16. Higher scores indicate greater acceptability.
Percentage of Sample With Valid Accelerometer Data at 6-weeks Follow-up	6-weeks follow-up assessment	The number of participants with valid accelerometer data out of the total number of participants in the sample during the 6-week follow-up assessment, multiplied by 100%.
Percentage of Ecological Momentary Assessment (EMA) Survey Prompt Completion	Baseline through 12-weeks follow-up assessments	The percentage of ecological momentary assessment (EMA) survey prompts completed by participants during the study out of the total number of EMA survey prompts delivered to participants.
Percentage of Sample With Valid Accelerometer Data at 2-weeks Follow-up	2-weeks follow-up assessment	The number of participants with valid accelerometer data out of the total number of participants in the sample during the 2-week follow-up assessment, multiplied by 100%.
Percentage of Sample With Valid Accelerometer Data at 12-weeks Follow-up	12-weeks follow-up assessment	The number of participants with valid accelerometer data out of the total number of participants in the sample during the 12-week follow-up assessment, multiplied by 100%.
Percentage of Sample With Valid Accelerometer Data at Baseline	Baseline assessment	The number of participants with valid accelerometer data out of the total number of participants in the sample at baseline, multiplied by 100%.
Number of Participants Who Completed the Exit Interview	12-weeks follow-up assessment	Semi-structured interview to assess participants' perceptions regarding their experience participating in the study.

Secondary Outcome Measures

Name	Time	Method
Satisfaction With Study Participation as Measured by the Participant Satisfaction Questionnaire	12-weeks follow-up assessment	An 8-item self-report questionnaire used to assess participant satisfaction with study participation using a Likert scale ranging from 1 to 4 . Scores are summed and then averaged; total scores range from 1- 4. Higher scores indicate greater satisfaction.
Study Retention at 12-weeks Follow-up	12-weeks follow-up assessment	Number of participants who complete the 12-week follow-up assessment out of the number of participants who enroll in the study.
Average Minutes of Daily Moderate-vigorous Physical Activity Measured Using the ActiGraph wGT3X-BT Accelerometer at 12 Weeks Follow-up	12-weeks follow-up assessment	The research grade ActiGraph wGT3X-BT model is a valid measure of physical activity intensity and duration among multiple populations, including breast cancer survivors. Minutes of moderate-vigorous physical activity will be collected from the ActiGraph wGT3X-BT every day for 10-days. Average minutes of moderate-vigorous physical activity completed per day of valid wear time will be calculated.
Study Retention at 2-weeks Follow-up	2-weeks follow-up assessment	Number of participants who complete the 2-week follow-up assessment out of the number of participants who enroll in the study.
Study Retention at 6-weeks Follow-up	6-weeks follow-up assessment	Number of participants who complete the 6-week follow-up assessment out of the number of participants who enroll in the study.